Diaphragm Electrical ActivityNCT07020299
Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease
A study testing Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction. in people with Diaphragm Electrical Activity and COPD (Chronic Obstructive Pulmonary Disease), run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD). This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Electrical Activity, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Known cases of COPD admitted at respiratory critical care unit with severe acute exacerbation (defined according to GOLD 2024).
Who cannot join
- Body mass index (BMI) > 35 kg/m2
- Post arrest patients
- Brain death
- Hemodynamic instability
- Invasive MV
- Lung disease other than COPD
Show all 13Show fewer
- Pregnancy , ascitis.
- History of neuromuscular disease at admission
- Spinal injuries
- Skin lesions or an open lesion in the regions where the electrodes would be placed
- Use of pacemakers
- Patients on maintenance steroid therapy
- Depletating disease as malignancy 14. Patients refusing the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trans-cutenuous Electrical Diaphragmatic Stimulation on Severe Chronic Obstructive Pulmonary Disease Exacerbation
Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).
This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions
Read the detailed description
Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).Weakness or fatigue of the diaphragm and accessory muscles of inspiration is widely recognized in patients on mechanical ventilation. There is increasing evidence to show mechanical ventilation itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction. However, in patients with more severe COPD, the benefits of rehabilitation may be limited. In this context, there are new approaches to PR, such as electrical stimulation, a technique that externally stimulates contractions of peripheral muscles to improve peripheral muscle function in patients with severe COPD. This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions
- Being tested
- Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.
- Keywords
- chronic obstructive pulmonary disease exacerbation, Electrical diaphragmatic stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.Device
TEDS group will be subjected to sessions of TEDS as follow : Digital electrical muscle stimulator (EV-906 Digital TENS/EMS made in TAIWAN) is applied to induce diaphragm contraction.
| Study group | Role | What they receive |
|---|---|---|
| TEDS group will be subjected to sessions of TEDS | Active comparator | TEDS group will be subjected to sessions of TEDS as follow : Digital electrical muscle stimulator (EV-906 Digital TENS/EMS made in TAIWAN) is applied to induce diaphragm contraction. Receives: Device: Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction. |
| Non TEDS group will not be subjected to sessions of TEDS | No intervention | Non TEDS group will not be subjected to sessions of TEDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the progression to invasive mechanical ventilation(IMV)
Functional assessment by US measurement of diaphragmatic excursion and thickness fraction in (cm) including base line measurement and post treatment measurement ( at the end of admission).
Measured: 6 months
Secondary outcomes (1)
The secondary outcomes is the duration of ICU admission
The secondary outcomes is the duration of ICU admission (days), the immediate effect of TEDS and after sessions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Aug 2024
- Primary completion1 Feb 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm Electrical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effect of trans-cutenuous electrical diaphragmatic stimulation on severe chronic obstructive pulmonary disease exacerbation
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed AbdElmoniem, lecturer, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020299
- Sponsor's protocol ID
- MD.24.08.878
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans-cutenuous Electrical Diaphragmatic Stimulation on Severe Chronic Obstructive Pulmonary Disease Exacerbation
- ClinicalTrials.gov ID
- NCT07020299
- Acronym / sponsor ID
- MD.24.08.878
- Keywords
- chronic obstructive pulmonary disease exacerbation, Electrical diaphragmatic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).
This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions
Detailed description
Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).Weakness or fatigue of the diaphragm and accessory muscles of inspiration is widely recognized in patients on mechanical ventilation. There is increasing evidence to show mechanical ventilation itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction. However, in patients with more severe COPD, the benefits of rehabilitation may be limited. In this context, there are new approaches to PR, such as electrical stimulation, a technique that externally stimulates contractions of peripheral muscles to improve peripheral muscle function in patients with severe COPD. This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Effect of trans-cutenuous electrical diaphragmatic stimulation on severe chronic obstructive pulmonary disease exacerbation
| Arm | Type | Receives |
|---|---|---|
| TEDS group will be subjected to sessions of TEDS | Active comparator | Device: Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.TEDS group will be subjected to sessions of TEDS as follow : Digital electrical muscle stimulator (EV-906 Digital TENS/EMS made in TAIWAN) is applied to induce diaphragm contraction. |
| Non TEDS group will not be subjected to sessions of TEDS | No intervention | –Non TEDS group will not be subjected to sessions of TEDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years.
- Known cases of COPD admitted at respiratory critical care unit with severe acute exacerbation (defined according to GOLD 2024).
Key exclusion criteria (13 listed)
- Body mass index (BMI) > 35 kg/m2
- Post arrest patients
- Brain death
- Hemodynamic instability
- Invasive MV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.TEDS group will be subjected to sessions of TEDS as follow : Digital electrical muscle stimulator (EV-906 Digital TENS/EMS made in TAIWAN) is applied to induce diaphragm contraction. | Device | TEDS group will be subjected to sessions of TEDS |
Primary outcome
The primary outcome is the progression to invasive mechanical ventilation(IMV)
Time frame: 6 months
Functional assessment by US measurement of diaphragmatic excursion and thickness fraction in (cm) including base line measurement and post treatment measurement ( at the end of admission).
1 secondary outcome
The secondary outcomes is the duration of ICU admission
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed AbdElmoniem, lecturer principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction. in people with Diaphragm Electrical Activity and COPD (Chronic Obstructive Pulmonary Disease), run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the progression to invasive mechanical ventilation(IMV) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.